HIV-1MEGAHOSTNCT06458504
Viral Infection of HSPC Impacts Hematopoiesis
An observational study of HIV-1 and SARS-CoV-2, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
We propose to demonstrate that HIV-1 and SARS-CoV-2 are capable of targeting long-lived HSPC with self-renewal capacities. These progenitors, thus transformed into host cells, can give rise to a durable source of infected cells with an impact on hematopoiesis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV-1, SARS-CoV-2
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- 25 Oct 2024to Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: * adult patients. * patients able to read and understand the information note. * no opposition to the use of biological samples. 45 subjects are required in our study: (A) 20 patients with FFPE osteomedullary biopsy prior to COVID-19 pandemic. Including : * 10 HIVpos patients selected based on biopsy results (normal, subnormal/minor lesion). * 10 HIVneg patients selected to match HIVpos patients, considering age and biological sex. (B) 25 HIVneg patients asymptomatic for COVID-19 for whom a myelogram or BM biopsy is prescribed as part of a search for haematological pathology or as part of lymphoma extension investigations.
Who may be able to join
- HIV patients :
- HIV-positive patients with a negative or positive viral load.
- managed at Ambroise Paré Hospital.
- patients with a bone marrow biopsy or myelogram performed as part of their care.
- Healthy subjects without HIV - patients with a BM biopsy or myelogram performed as part of their care for a suspected hematological pathology.
- Management at Ambroise Paré Hospital.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hematology and interne medicine department, Ambroise Paré hospital - APHP
Boulogne-Billancourt, 92100
About this study
Official title: Virus-induced Immunosuppression Via Infection of Hematopoietic Progenitors
We propose to demonstrate that HIV-1 and SARS-CoV-2 are capable of targeting long-lived HSPC with self-renewal capacities. These progenitors, thus transformed into host cells, can give rise to a durable source of infected cells with an impact on hematopoiesis.
Read the detailed description
Virus-induced immunosuppression is the transient or persistent decline of immune cell counts and/or function caused by a virus, favouring its persistence in the host organisms. When sustained, triggered by acute viral replication or maintained by chronic viral infections, virus-induced immunosuppression is a life-threatening condition. It is notoriously observed in chronic HIV-1 infection and even in a considerable fraction of antiretroviral-treated HIV-infected individuals. It is also observed in some individuals recovering from severe and mild-to-moderate COVID-19. Its mechanisms are elusive and efficient therapeutic options are not available. Virus-induced immunosuppression may occur in the periphery (affecting circulating immune cells) or in the bone marrow, affecting hematopoietic stem and progenitor cells (HSPC) and hematopoiesis. Several viruses can infect HSPCs. HIV-1 can directly infect HSC, negatively impacting HSC function and the whole stem cell environment of the bone marrow. Whether HSC can be productively infected by SARS-CoV-2 or just targeted and modulated by it remains uncertain and further studies are required to determine HSPC susceptibility or viral sensing for SARS-CoV-2. Therefore, we will i) Evaluate which hematopoietic stem and progenitor cells (HSPC) are targeted by HIV-1 (in vivo and ex vivo) and SARS-CoV-2 (ex vivo); ii) Evaluate whether these infected HSPC would modulate the bone marrow environment by upregulating inflammatory cytokines detrimental to lymphopoiesis.
- Conditions
- HIV-1, SARS-CoV-2
- Keywords
- HIV-1, SARS-CoV-2, Hematopoietic Progenitors, Virus-induced, Immunosuppression
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate if infected HSPC would modulate the bone marrow environment
Evaluate whether these infected HSPC would modulate the bone marrow environment by upregulating inflammatory cytokines detrimental to lymphopoiesis.
Measured: at 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start25 Oct 2024
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV-1Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claude CAPRON, MD, PhD, Principal investigator, Laboratory of Immunology, Ambroise Paré hospital - APHPFernando REAL, PhD, Study director, Center for Infection and Immunity of Lille, INSERM U1019 - CNRS UMR9017, Institut Pasteur de Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06458504
- Sponsor's protocol ID
- APHP240419
- Other IDs
- 2024-A00117-40
- Acronym
- MEGAHOST
- Status last verified
- Mar 2025
- First submitted
- 10 Jun 2024
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virus-induced Immunosuppression Via Infection of Hematopoietic Progenitors
- ClinicalTrials.gov ID
- NCT06458504
- Acronym / sponsor ID
- MEGAHOST / APHP240419
- Conditions
- HIV-1, SARS-CoV-2
- Keywords
- HIV-1, SARS-CoV-2, Hematopoietic Progenitors, Virus-induced, Immunosuppression
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 25 Oct 2024 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 13 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We propose to demonstrate that HIV-1 and SARS-CoV-2 are capable of targeting long-lived HSPC with self-renewal capacities. These progenitors, thus transformed into host cells, can give rise to a durable source of infected cells with an impact on hematopoiesis.
Detailed description
Virus-induced immunosuppression is the transient or persistent decline of immune cell counts and/or function caused by a virus, favouring its persistence in the host organisms. When sustained, triggered by acute viral replication or maintained by chronic viral infections, virus-induced immunosuppression is a life-threatening condition. It is notoriously observed in chronic HIV-1 infection and even in a considerable fraction of antiretroviral-treated HIV-infected individuals. It is also observed in some individuals recovering from severe and mild-to-moderate COVID-19. Its mechanisms are elusive and efficient therapeutic options are not available. Virus-induced immunosuppression may occur in the periphery (affecting circulating immune cells) or in the bone marrow, affecting hematopoietic stem and progenitor cells (HSPC) and hematopoiesis. Several viruses can infect HSPCs. HIV-1 can directly infect HSC, negatively impacting HSC function and the whole stem cell environment of the bone marrow. Whether HSC can be productively infected by SARS-CoV-2 or just targeted and modulated by it remains uncertain and further studies are required to determine HSPC susceptibility or viral sensing for SARS-CoV-2. Therefore, we will i) Evaluate which hematopoietic stem and progenitor cells (HSPC) are targeted by HIV-1 (in vivo and ex vivo) and SARS-CoV-2 (ex vivo); ii) Evaluate whether these infected HSPC would modulate the bone marrow environment by upregulating inflammatory cytokines detrimental to lymphopoiesis.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * adult patients. * patients able to read and understand the information note. * no opposition to the use of biological samples. 45 subjects are required in our study: (A) 20 patients with FFPE osteomedullary biopsy prior to COVID-19 pandemic. Including : * 10 HIVpos patients selected based on biopsy results (normal, subnormal/minor lesion). * 10 HIVneg patients selected to match HIVpos patients, considering age and biological sex. (B) 25 HIVneg patients asymptomatic for COVID-19 for whom a myelogram or BM biopsy is prescribed as part of a search for haematological pathology or as part of lymphoma extension investigations.
Key inclusion criteria (6 listed)
- HIV-positive patients with a negative or positive viral load.
- managed at Ambroise Paré Hospital.
- patients with a bone marrow biopsy or myelogram performed as part of their care.
- Healthy subjects without HIV - patients with a BM biopsy or myelogram performed as part of their care for a suspected hematological pathology.
- Management at Ambroise Paré Hospital.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluate if infected HSPC would modulate the bone marrow environment
Time frame: at 1 year
Evaluate whether these infected HSPC would modulate the bone marrow environment by upregulating inflammatory cytokines detrimental to lymphopoiesis.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Claude CAPRON, MD, PhD principal investigator
Laboratory of Immunology, Ambroise Paré hospital - APHP
Fernando REAL, PhD study director
Center for Infection and Immunity of Lille, INSERM U1019 - CNRS UMR9017, Institut Pasteur de Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIV-1 and SARS-CoV-2, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claude CAPRON, MD, PhD (+ 33 01 49 09 58 47, claude.capron@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate if infected HSPC would modulate the bone marrow environment (time frame: at 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025.